Intuition vs. Deliberation in Medical Decision Making

Intuition Versus Deliberation in Decisions About Life-Sustaining Medical Therapies

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02487810

Enrollment

200

Registered

2015-07-02

Start date

2015-07-31

Completion date

2016-03-31

Last updated

2019-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Making About Life-sustaining Treatment in Patients With Serious Cardiac, Respiratory and Oncological Conditions Likely to Limit Life Expectancy

Brief summary

The purpose of this study is to determine whether there are systematic differences between the decisions patients make intuitively versus deliberatively about life-sustaining medical therapies. The targeted population is inpatients at the Hospital of the University of Pennsylvania with serious medical problems. The study will involve facilitated interviews with patients using a survey instrument developed in Qualtrics.

Interventions

BEHAVIORALCognitive load

Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.

BEHAVIORALDeliberative instructions

Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age 60 and older 2. Currently an inpatient at Hospital of the University of Pennsylvania 3. Speaks and reads fluently in English 4. Either 1. Has one of the following medical conditions: * Chronic obstructive pulmonary disease with at least severe airflow obstruction on most recent spirometry and/or eligible for long-term oxygen therapy * Incurable interstitial lung disease with at least severe restriction on most recent pulmonary function tests and/or eligible for long-term oxygen therapy * Congestive heart failure with NYHA Class III or higher and current hospitalization related to heart failure * Acute myeloid leukemia * Stage IV lymphoma * Stage IIIB or Stage IV non-small cell lung cancer, cholangiocarcinoma, renal cell carcinoma, breast cancer, uterine cancer, cervical cancer, ovarian cancer, colorectal cancer, gastric cancer, pancreatic cancer, prostate cancer, urothelial cancer * Stage C or D hepatocellular carcinoma * Mesothelioma or any malignancy metastatic to the pleura; or 2. Is hospitalized on oncology, pulmonary or cardiology service and has been hospitalized at least one other time during the last year on the same service 5. Stable vital signs

Exclusion criteria

1. Notation of code status limitation in electronic medical record 2. Cognitive impairment to the point unable to give informed consent 3. Current feeding tube placement 4. Current tracheostomy 5. Severe pain, shortness of breath or other uncontrolled symptoms 6. Actively undergoing evaluation for solid organ transplant 7. First hospitalization after diagnosis of serious illness

Design outcomes

Primary

Measure	Time frame	Description
Acceptance or Refusal of a Feeding Tube for Chronic Aspiration	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of a feeding tube for chronic aspiration. In this hypothetical scenario, patients are presented with a situation in which they are unable to eat or drink safely such that small amounts of food or liquid go to their lungs and cause trouble with breathing. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
Acceptance or Refusal of Antibiotics	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of antibiotics. In this hypothetical scenario, patients are presented with an illness severity such that they drift in and out of consciousness some days and are expected to die in several months. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
Acceptance or Refusal of Breathing Machine	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of a breathing machine. In this hypothetical scenario, patients are presented with a life-threatening illness with 50% chance of survival provided that they receive support from a breathing machine for two weeks. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
Acceptance or Refusal of Tracheostomy	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of a tracheostomy and support from a breathing machine for at least two months to survive. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.

Secondary

Measure	Time frame	Description
Correlation Between Accepting Antibiotics and Thinking That Needing Care All the Time is Equal to or Worse Than Death	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	This outcome measures the proportion of participants who accept antibiotics AND indicate that needing care all the time is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.
Correlation Between Accepting Tracheostomy and Thinking That Living in a Nursing Home is Equal to or Worse Than Death	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	This outcome measures the proportion of participants who accept tracheostomy AND indicate that living in a nursing home is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.
Scores on Uncertainty Subscale of Decisional Conflict Scale	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	Decisional uncertainty will be evaluated using the uncertainty subscale of the Decisional Conflict Scale ranging from 0-100 such that 0 = extremely CERTAIN about best choice and 100 = extremely UNCERTAIN about the best choice. Higher values represent MORE UNCERTAINTY with decisions regarding feeding tubes, antibiotics, intubation, and tracheostomy while lower values represent LESS UNCERTAINTY.
Correlation Between Accepting Tracheostomy and Thinking That Relying on a Breathing Machine is Equal to or Worse Than Death	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	This outcome measures the proportion of participants who accept tracheostomy AND indicate that relying on a breathing machine is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.
Correlation Between Accepting a Feeding Tube and Thinking That Relying on a Feeding Tube is Equal to or Worse Than Death	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	This outcome measures the proportion of participants who accept a feeding tube AND indicate that relying on a feeding tube is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.
Correlation Between Accepting Antibiotics and Thinking That Living in a Nursing Home is Equal to or Worse Than Death	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	This outcome measures the proportion of participants who accept antibiotics AND indicate that living in a nursing home is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.
Correlation Between Accepting Tracheostomy and Thinking That Being Bed Bound is Equal to or Worse Than Death	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	This outcome measures the proportion of participants who accept tracheostomy AND indicate that bed bound is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.
Correlation Between Accepting Antibiotics and Thinking That Being Bed Bound is Equal to or Worse Than Death.	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	This outcome measures the proportion of participants who accept antibiotics AND indicate that bed bound is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.
Correlation Between Accepting Tracheostomy and Thinking That Needing Care All the Time is Equal to or Worse Than Death	The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally	This outcome measures the proportion of participants who accept tracheostomy AND indicate that needing care all the time is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Intuitive Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.	97
Deliberative Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding medical interventions. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Deliberative instructions: Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions	102
Total	199

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Intuitive	Deliberative	Total
Age, Continuous	66.5 years STANDARD_DEVIATION 4.8	67.9 years STANDARD_DEVIATION 5.2	67.2 years STANDARD_DEVIATION 5
Sex: Female, Male Female	33 Participants	34 Participants	67 Participants
Sex: Female, Male Male	64 Participants	68 Participants	132 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 97	0 / 102
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

Acceptance or Refusal of a Feeding Tube for Chronic Aspiration

Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of a feeding tube for chronic aspiration. In this hypothetical scenario, patients are presented with a situation in which they are unable to eat or drink safely such that small amounts of food or liquid go to their lungs and cause trouble with breathing. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.